AsthmaPhase 2GINGERNCT07792395
Ginger's Therapeutic Potential in Asthma
A Phase 2 study testing Ginger Extract in people with Asthma, run by Emily DiMango, MD at 1 site in United States.
Trial summary
Primary Objective: The primary endpoint is a clinically significant improvement in tolerance to inhaled methacholine (PD20). Secondary Objectives: 1) To determine if oral daily ginger extract intake - decreases fractional excretion of nitric oxide; decreases blood eosinophilia; decreases asthma-associated cytokines in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Ginger Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older with mild to severe persistent asthma as defined by NIH National Asthma Education and Prevention Program (NAEPP) guidelines, with asthma that is not optimally controlled despite current use of inhaled corticosteroids with or without inhaled long-acting beta agonists.
- Treatment with inhaled corticosteroids (ICS), with or without long-acting beta-agonists/long-acting muscarinic antagonists and montelukast.
- Physician-diagnosed asthma confirmed by history/report, pulmonary function testing with FEV1 ≥60% predicted or ≥1.5 L, and methacholine testing with baseline methacholine PD20 <16 mg/mL if taking ICS or <8 mg/mL if not taking ICS at Visit 2.
- Non-smoker of tobacco, e-cigarettes, or marijuana for ≥1 year. Nicotine patch or gum is permitted.
- Smoking history of ≤10 pack-years.
- Suboptimal asthma control as determined by an Asthma Control Test (ACT) score ≤19 at the Screening and Randomization Visits.
- Ability to understand English or Spanish, understand the study procedures, and comply with them f r the entire study period.
- Participants of childbearing potential must have negative urine pregnancy testing as required by the protocol and agree to use effective contraception during the trial.
Who cannot join
- Major chronic illness that, in the judgment of the study physician, would interfere with study participation, including non-skin cancer, uncontrolled diabetes mellitus, coronary artery disease, congestive heart failure, stroke, severe hypertension, renal failure, liver disorders, malabsorption disorders, immunodeficiency states, major neuropsychiatric disorders, or seizure disorders.
- Cardiovascular conditions including myocardial infarction or stroke within the previous 3 months, uncontrolled hypertension, or known aortic aneurysm.
- History of physician-diagnosed chronic bronchitis, emphysema, or COPD.
- Current use of ginger supplements.
- Oral corticosteroid use within the previous 6 weeks.
- Use of an investigational treatment within the previous 30 days.
Show all 11Show fewer
- Use of anticoagulants, such as warfarin, rivaroxaban, or similar agents.
- Known adverse reaction to ginger or ginger products.
- Cancer other than skin cancer.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Charles Emala, MD contact
United States1 site
Columbia University Asthma Center
New York, New York, 10032
About this study
Official title: Ginger's Therapeutic Potential in Asthma - Phase 2a
Primary Objective: The primary endpoint is a clinically significant improvement in tolerance to inhaled methacholine (PD20).
Secondary Objectives: 1) To determine if oral daily ginger extract intake - decreases fractional excretion of nitric oxide; decreases blood eosinophilia; decreases asthma-associated cytokines in serum; decreases medium chain fatty acids; improves asthma symptoms; and 2) Establish pharmacokinetic parameters of biologically active components of ginger in adult asthmatics.
Read the detailed description
The study is based on preclinical evidence that active ginger components and their metabolites can relax airway smooth muscle and reduce lung inflammation, potentially through inhibition of phospholipase C (PLC), which is involved in both airway constriction and inflammatory cytokine release. The trial will evaluate whether oral ginger improves airway hyperresponsiveness, measured by tolerance to inhaled methacholine, and reduces markers of inflammation in adults with asthma. It will also assess the bioavailability and pharmacokinetics of active ginger metabolites.
The selected ginger formulation and doses of 2-3 g/day were chosen based on prior human studies demonstrating generally good tolerability, with mostly mild gastrointestinal side effects. Because of limited evidence that ginger may affect platelet aggregation, participants taking anticoagulant medications will be excluded.
- Conditions
- Asthma
- Being tested
- Ginger Extract, Placebo
- Keywords
- Ginger, Dietary supplement
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger ExtractDrug
Also called Ginger
2gm or 3gm capsule of Ginger Extract
PlaceboDrug
Also called Placebo pill
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Active drug - Placebo (2gm) | Experimental | Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days, followed by washout period, then will receive matching placebo for 56 days. Receives: Drug: Ginger Extract; Drug: Placebo |
| Placebo - Active Drug (2gm) | Experimental | Subjects assigned to the placebo group will receive a matching placebo for 56 days, followed by washout period, then will receive 2 grams daily of Ginger Extract for 56 days. Receives: Drug: Ginger Extract; Drug: Placebo |
| Active drug - Placebo (3gm) | Experimental | Subjects assigned to the intervention will receive 3 grams daily of Ginger Extract for 56 days, followed by washout period, then will receive matching placebo for 56 days. Receives: Drug: Ginger Extract; Drug: Placebo |
| Placebo - Active Drug (3gm) | Experimental | Subjects assigned to the placebo group will receive a matching placebo for 56 days, followed by washout period, then will receive 3 grams daily of Ginger Extract for 56 days. Receives: Drug: Ginger Extract; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD20 dose of methacholine
To measure any change in airway hyperresponsiveness following treatment with oral ginger compared with placebo, assessed by methacholine bronchoprovocation testing. Methacholine PD20 is the dose of inhaled methacholine that produces a 20% decrease in FEV1 from the post-diluent baseline. A clinically significant improvement is defined in the protocol as a 0.7 increase in the doubling dose of inhaled methacholine from the participant's baseline.
Measured: Baseline, 56 days
Secondary outcomes (6)
Change in fractional excretion of nitric oxide (FENO)
Measure of markers of asthmatic lung inflammation
Measured: Baseline and 56 days
Change in Blood Eosinophilia
Blood eosinophil counts will be used as a marker of asthma-associated inflammation. Blood samples will be obtained and processed.
Measured: Baseline and 56 days
Asthma-associated cytokines in serum level
To measure any change in levels of asthma-associated inflammatory cytokines following treatment with oral ginger compared with placebo. Cytokines will be measured in blood samples using multiplex cytokine analysis.
Measured: Baseline, 56 days
Medium chain fatty acids level
To measure any change in blood levels of medium-chain fatty acids following treatment with oral ginger compared with placebo. Medium-chain fatty acids will be assessed as biomarkers of asthma-associated inflammation.
Measured: Baseline, 56 days
ACT Score
Asthma symptoms following treatment with oral ginger compared with placebo will be assessed using the Asthma Control Test (ACT). The ACT is a 5-question, 4-week recall questionnaire assessing asthma control, symptoms, and nocturnal awakenings, with scores ranging from 5 (poor control) to 25 (complete control).
Measured: 56 days
Plasma concentration
This is to measure pharmacokinetic parameters of biologically active components of ginger in adult asthmatics. Plasma concentrations of biologically active ginger components and/or metabolites will be measured and quantified in a subgroup of participants to characterize their pharmacokinetic profile.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emily DiMango, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Emily DiMango, MD, Columbia University
- Investigators
- Emily DiMango, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792395
- Sponsor's protocol ID
- ACYY2084
- Other IDs
- R33AT012627
- Acronym
- GINGER
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ginger's Therapeutic Potential in Asthma - Phase 2a
- ClinicalTrials.gov ID
- NCT07792395
- Acronym / sponsor ID
- GINGER / ACYY2084
- Conditions
- Asthma
- Keywords
- Ginger, Dietary supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Emily DiMango, MDUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective: The primary endpoint is a clinically significant improvement in tolerance to inhaled methacholine (PD20).
Secondary Objectives: 1) To determine if oral daily ginger extract intake - decreases fractional excretion of nitric oxide; decreases blood eosinophilia; decreases asthma-associated cytokines in serum; decreases medium chain fatty acids; improves asthma symptoms; and 2) Establish pharmacokinetic parameters of biologically active components of ginger in adult asthmatics.
Detailed description
The study is based on preclinical evidence that active ginger components and their metabolites can relax airway smooth muscle and reduce lung inflammation, potentially through inhibition of phospholipase C (PLC), which is involved in both airway constriction and inflammatory cytokine release. The trial will evaluate whether oral ginger improves airway hyperresponsiveness, measured by tolerance to inhaled methacholine, and reduces markers of inflammation in adults with asthma. It will also assess the bioavailability and pharmacokinetics of active ginger metabolites.
The selected ginger formulation and doses of 2-3 g/day were chosen based on prior human studies demonstrating generally good tolerability, with mostly mild gastrointestinal side effects. Because of limited evidence that ginger may affect platelet aggregation, participants taking anticoagulant medications will be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active drug - Placebo (2gm) | Experimental | Drug: Ginger Extract, Drug: PlaceboSubjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days, followed by washout period, then will receive matching placebo for 56 days. |
| Placebo - Active Drug (2gm) | Experimental | Drug: Ginger Extract, Drug: PlaceboSubjects assigned to the placebo group will receive a matching placebo for 56 days, followed by washout period, then will receive 2 grams daily of Ginger Extract for 56 days. |
| Active drug - Placebo (3gm) | Experimental | Drug: Ginger Extract, Drug: PlaceboSubjects assigned to the intervention will receive 3 grams daily of Ginger Extract for 56 days, followed by washout period, then will receive matching placebo for 56 days. |
| Placebo - Active Drug (3gm) | Experimental | Drug: Ginger Extract, Drug: PlaceboSubjects assigned to the placebo group will receive a matching placebo for 56 days, followed by washout period, then will receive 3 grams daily of Ginger Extract for 56 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years or older with mild to severe persistent asthma as defined by NIH National Asthma Education and Prevention Program (NAEPP) guidelines, with asthma that is not optimally controlled despite current use of inhaled corticosteroids with or without inhaled long-acting beta agonists.
- Treatment with inhaled corticosteroids (ICS), with or without long-acting beta-agonists/long-acting muscarinic antagonists and montelukast.
- Physician-diagnosed asthma confirmed by history/report, pulmonary function testing with FEV1 ≥60% predicted or ≥1.5 L, and methacholine testing with baseline methacholine PD20 <16 mg/mL if taking ICS or <8 mg/mL if not taking ICS at Visit 2.
- Non-smoker of tobacco, e-cigarettes, or marijuana for ≥1 year. Nicotine patch or gum is permitted.
- Smoking history of ≤10 pack-years.
Key exclusion criteria (11 listed)
- Major chronic illness that, in the judgment of the study physician, would interfere with study participation, including non-skin cancer, uncontrolled diabetes mellitus, coronary artery disease, congestive heart failure, stroke, severe hypertension, renal failure, liver disorders, malabsorption disorders, immunodeficiency states, major neuropsychiatric disorders, or seizure disorders.
- Cardiovascular conditions including myocardial infarction or stroke within the previous 3 months, uncontrolled hypertension, or known aortic aneurysm.
- History of physician-diagnosed chronic bronchitis, emphysema, or COPD.
- Current use of ginger supplements.
- Oral corticosteroid use within the previous 6 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger ExtractAlso: Ginger2gm or 3gm capsule of Ginger Extract | Drug | Active drug - Placebo (2gm), Active drug - Placebo (3gm), Placebo - Active Drug (2gm), Placebo - Active Drug (3gm) |
| PlaceboAlso: Placebo pillMatching placebo | Drug | Active drug - Placebo (2gm), Active drug - Placebo (3gm), Placebo - Active Drug (2gm), Placebo - Active Drug (3gm) |
Primary outcome
PD20 dose of methacholine
Time frame: Baseline, 56 days
To measure any change in airway hyperresponsiveness following treatment with oral ginger compared with placebo, assessed by methacholine bronchoprovocation testing. Methacholine PD20 is the dose of inhaled methacholine that produces a 20% decrease in FEV1 from the post-diluent baseline. A clinically significant improvement is defined in the protocol as a 0.7 increase in the doubling dose of inhaled methacholine from the participant's baseline.
6 secondary outcomes
Change in fractional excretion of nitric oxide (FENO)
Time frame: Baseline and 56 days
Change in Blood Eosinophilia
Time frame: Baseline and 56 days
Asthma-associated cytokines in serum level
Time frame: Baseline, 56 days
Medium chain fatty acids level
Time frame: Baseline, 56 days
ACT Score
Time frame: 56 days
Plasma concentration
Time frame: 56 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Emala, MD contact
Emily DiMango, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ginger Extract in people with Asthma, run by Emily DiMango, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily DiMango, MD ((212)305-0631, ead3@columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD20 dose of methacholine (time frame: Baseline, 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.